Raghu Rama Krishna K
Senior Executive Quality Assurance @Granules India Limited
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WORK HISTORY
Senior Executive Quality Assurance @Granules India Limited
1 year’ experience conducting in-process checks and verifying that all steps in the manufacturing process are followed correctly & ensuring accurate and timely completion of batch records and other quality documentation.
EDUCATION
Andhra University
B.Sc, Chemistry
BOARD OF SECONDARY EDUCATION
S.S.C
Sri Venkateswara University
Master of Science, Chemistry
Sri Venkateswara University
M.Sc, Organic Chemistry
Andhra University
BACHELOR OF SCIENCE (B.SC), MATHEMATICS, PHYSICS AND CHEMISTRY
SVU UNIVERSITY
MASTER OF SCIENCE (M.SC), CHEMISTRY (ORGANIC CHEMISTRY AS; SPECIALIZATION
ABOUT RAGHU RAMA KRISHNA K
17+ years experience in pharmaceutical and medical device industry, Lead GMP/GxP Auditor, SME in GMP and GDP compliance, core knowledge in validation and Qualifications, Computer system validation, simplification and Digitisation of QMS.Currently working as Lead Quality systems and compliance manager and responsible for new product launches into Europe market, supplier qualification, batch releases, QMS remediation activities, Qualified GMP auditor at Dr. Reddy’s laboratories.Core competencies including change controls, CAPA, Risk Assessment, Troubleshooting, Problem Solving, GMP compliance, regulatory knowledge in ISO 9001, ISO 13485, ISO14001, ISO 27001, ISO FDA and EMA guidelines, implementation of digital quality platforms like electronic document management, electronic change management, electronic learning management, CAPa Management, etc and experience of facing many regulatory inspections USFDA, MHRA, EMA, PMDA, TGA, WHO.etc. Expertise in preparation of SOP’s & Guidance documents as per current regulatory standards and operational requirements.
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